The TRICURE EU Pivotal Study
NCT06581471 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-04-15
Summary
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Conditions
- Tricuspid Valve Regurgitation
- Heart Valve Disease
- Cardiovascular Diseases
Interventions
- DEVICE
-
Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Sponsors & Collaborators
-
TRiCares
lead INDUSTRY
Principal Investigators
-
Jörg Hausleiter, MD · LMU Munich
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-29
- Primary Completion
- 2026-10-30
- Completion
- 2030-12-30
Countries
- Belgium
- Germany
Study Locations
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